DIFFUSION PACKAGE / GYROSCAN NT

DIFFUSION PACKAGE / GYROSCAN NT is an FDA 510(k)-cleared medical device (K973658) manufactured by Philips Medical Systems North America, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 5, 1998. Regulation: 8.